Clinical Trials Register

Summary
EudraCT Number:	2006-005261-19
Sponsor's Protocol Code Number:	CVAL489K2303
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-02-15
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2006-005261-19

A.3

Full title of the trial

A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 6 months-5 years old with hypertension, followed by a 2 week placebo withdrawal period

A.4.1

Sponsor's protocol code number

CVAL489K2303

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Pharma Services AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Diovan 160
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma NV
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Valsartan
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hypertension

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate a dose dependent reduction in MSSBP when comparing three doses of valsartan (0.25 mg,/kg, 1 mg/kg and 4 mg/kg ) over a 6 week period in children
6 months-5 years old with hypertension ( ≥ 95th percentile).

E.2.2

Secondary objectives of the trial

• To evaluate the overall safety and tolerability of valsartan in 6 months to 5 year old
hypertensive children when treated for up to 6 weeks.
• To evaluate blood pressure change at the end of Period 2 from end of Period 1,
when comparing pooled valsartan patients versus pooled placebo patients.

Exploritory Objectives:
• Explore the change in blood pressure (MSSBP and MSDBP) from baseline to end of
Period 2 in the subpopulation of patients who continued on valsartan in both
Period 1 and Period 2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who are eligible and able to participate in the study and whose parent
(s)/guardian(s) consent in writing (written informed consent) to their doing so
after the purpose and nature of the investigation has been clearly explained.
2. Male or female between the ages of 6 months to 5 years, at visit 1 with a documented
history of hypertension.
3. Must be able to swallow the liquid formulation of the study medication
4. Must be ≥ 8 kg or ≤ 40 kg
5. Patients, either naïve or treated, must have a documented history of a mean
seated systolic blood pressure (mean of three measurements), equal to or
greater than 95th percentile (Appendix 3). For children under 1 year of age see appendix 4. For all patients, mean seated systolic blood pressure should be equal to or greater than 95th percentile at randomization.
6. Patients with uncontrolled blood pressure, receiving background antihypertensive
therapy, may continue on this therapy provided there is no change in dosing
regimen.
7. Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the
local language.

E.4

Principal exclusion criteria

For full list, please refer to protocol.
1. Patients whose mean seated systolic blood pressure (mean of three
measurements), at the baseline visit (Visit # 2) is ≥ 25% higher than the 95th
percentile Appendix 3. For children under 1 year of age see Appendix 4.
2. Physical examination of patient demonstrates abnormalities that would make
this study medically hazardous to the patient.
3. Patients with background ARB therapy.
4. Patients that demonstrate any clinically significant abnormalities or clinically
noteworthy abnormal laboratory values (other than those relating to renal
function), including but not limited to the following:
• AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
• Total bilirubin > 2 times the upper limit of the reference range
• Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz
formula to estimate glomerular filtration rate [GFR], see section 7.5.5 for
formula, based on the serum creatinine concentration obtained at Visit 1
(Screening).
• WBC count < 3000/mm³
• Platelet count < 100,000/mm³
• Serum potassium > upper limit of the reference range
5. Patients that demonstrate clinically significant ECG abnormalities other than
those associated with left ventricular hypertrophy and AV block controlled with a
pacemaker.
6. Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or
renal artery stenosis.
7. Patient that has any clinically significant unstable medical condition or chronic
disease that would put the patient at risk of experiencing an adverse event
associated with the expected pharmacodynamic effects of the study medication.
8. Patient that has experienced a significant clinical illness within 10 days prior to
baseline visit.
9. Patient that is known to have tested positive for the hepatitis B surface antigen
or hepatitis C antibody.
10. Patient that is known to have tested seropositive for the human
immunodeficiency virus (HIV) or patient is concomitantly receiving anti-retroviral
therapy.
11. Patients that had a previous solid organ transplantation < 1 year prior to Visit 1 is excluded. Patient whose transplantation was performed ≥ 1 year prior to Visit 1 must be on stable doses of immunosuppresive therapy and deemed clinically stable by the clinician, to be enrolled. Stable doses of immunosuppressive therapy are defined as no change in frequency or total daily doses of immunosuppressive therapy for at least 3 months prior to screening . Doses of immunosuppressive therapy must be maintained throughout Periods 1 & 2 of the study.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in MSSBP (mean sitting systolic blood pressure)

The primary analysis is for change from baseline at the Period I endpoint in a dose dependent manner. Baseline is defined as the Week 0 value. The Period I endpoint is defined as the Week 6 value or the last post-baseline observation during Period I carried forward (LOCF).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.5

Children (2-11years)

Yes

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children of low age (see F1).

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-04-23

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials